Health TrialsbyHealthPanel

Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

ConditionLiver Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly >12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.6.

MELD < 25

Understanding the Swedish language.

Signed informed consent.

Disqualifiers

Performance status ≥3.

Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.

Previously liver transplanted

Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care advice on physical activity

    Behavioral

    Oral advice on exercise from a physician.

  • Structured advice on physical activity

    Behavioral

    A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Active interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in quality of life summary score, as measured with the CLDQ tool

Change in quality of life, as measured with the CLDQ tool (gives a summary score between 1-7, a higher score suggests a better quality of life).

Time frame
3 months

Secondary outcomes

1

Frailty

Frailty as measured with the Liver Frailty Index.

Time frame
3 months
2

MELD

Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)

Time frame
3 months
3

Mortality

Overall mortality

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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